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International Multi-center Clinical Trials

, [Crowne Plaza Century Park] Shanghai, China

The Most Practical and Exclusive Conference for Global Clinical Trials

SHANGHAI, CHINA, 09-10 DECEMBER 2010 – International Multi-center Clinical Trials are considered a quick method for pharmaceutical companies to get their products into the global market. Currently, over 15,000 global clinical trials are being conducted in the larger Asia Pacific market, which includes a growing number of trials conducted in China. According to the SFDA, there is increasing popularity to use China as a location for clinical trials, and many more pharmaceutical companies are also choosing China as their global clinical trial center.

To provide an inside view into global clinical trials in China, Noppen, in co-organization with the Shanghai Clinical Research Centre (SCRC), brought the International Multi-center Clinical Trials conference to Shanghai on the 9-10 December 2010. As the 4th Annual Conference in Noppen's Clinical Trial Series and supported by the American General Business Association (AGBA), it was a platform to help over 70 industry leaders optimize global clinical processes while ensuring regulatory compliance. It provided knowledge of changing government regulations and helped build a clinical strategy to successfully introduce products quickly to the market.

Zhang Kan, Director of the Department of Medical Science, Technology and Education at Shanghai Municipal Health Bureau gave a speech on translational medicine. He emphasized that hospitals and pharmaceutical companies should work together translating the results of clinical trials into changes in clinical practice, linking the basic scientific discovery with the clinical reality. Dr. Li Wei is Drug and Devices Reviewer for the SFDA; and also Director at the Cardiovascular Institute & Fuwai Hospital. She presented on superiority and non-inferiority study design, explaining the evaluation criteria of SFDA, and used an up-to-date case study to help the audiences understand the deep content. It was one of the top speeches at the conference and was well received by delegates.

Dr. Jiang Lixin, Co-Director at the China Oxford Center for International Health Research, was one of the most notable speakers at the event. Her speech on the operation and management methods of international multi-center clinical trials in China was inspiring to attendees. Dr. Stephen Porter, Chairman and CEO of VDDI Pharmaceutical, is knowledgeable in various fields of clinical trials and has over 25 years experience in Asia and China. He spoke about medical imaging in clinical trials and surrogate end point discussions. “The presentation topics were good and the content varied“ Simcere Dr. Ang Qiuqing, Clinical Development Director at GSK, who used to be a Medical Director for Eli Lily, gave an overview on conducting IMCT in China. She introduced the common issues in global clinical trials and gave her experienced suggestions to the delegates. In addition, Dr. William Wang, Head of the Asia Pacific hub at Merck Research Laboratories presented an evaluation of regional differences in multi-regional clinical development. He used an analysis of case studies to give the attendees a better understanding. “It is valuable to gather professionals from different countries to discuss global clinical trials in China” Fuwai Hospital

Industry experts such as Dr. Zheng Qingshan, Director of Clinical Research Center in Shanghai University of Traditional Chinese Medicine, introduce the enrichment design of clinical trials and from Fudan University, Prof. Hu Shanlian, the top expert in pharmacoeconomics, delivered a speech on pharmacoeconomics application in clinical trials. The concept was new to most of the delegates and the Q&A session went on for a lengthy time. “I’m impressed by the rich content of the event and it is very useful to my future work.” Eli LilyProminent speakers at the event also included Prof. Su Binghua, Chief Statistician from Tigermed Consulting who is well known in the industry. His speech brought fresh information and ideas that delegates could study and apply to their own projects. "Wonderful, very good” Jointwell Group Jack Xu, Vice President of Shanghai Clinical Research Center delivered a speech on how to conduct successful global clinical trials in China. His profound knowledge of clinical trials made for a great presentation; and Dr, Li Huafang, Director of MICT from Shanghai Mental Health Center addressed global clinical trials from a psychotropic perspective."Very good seminar, I hope that you will organize it regularly and invite more companies to attend” Philips China

On day one was a panel discussion on the “Partnership Between Pharmaceutical Companies and Hospitals — Building Mutually Beneficial Relations”. Moderated by Dr. Stephen Porter, Chairman and CEO of VDDI Pharmaceutical, panel guests included Dr. Ang Qiuqing, GSK R&D China; Dr. Chen Xiaoxiang, Vice President in Charge of Medical Division, Boehringer Ingelheim and Dr. Li Huafang, Shanghai Mental Health Center. They shared their personal experiences on hospital selection and trial management skills. Dr. Li Huafang also gave her opinion from the hospitals point of view. Overall it was a very successful and informative event and the delegates are already looking forward to the 2011 event. "The event was very well organized”Nobel Biocare AG

International Multi-center Clinical Trials

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